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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / December 2025 / K252145

510(k) cleared

GEN5 and GEN5+ 3.3mmD Dental Implants

Paragon Implant Mfg., LLC · Dec 23, 2025 · K252145

FDA cleared the GEN5 and GEN5+ 3.3mmD Dental Implants from Paragon Implant Mfg., LLC on Dec 23, 2025 under K252145, a traditional 510(k). The device falls under product code DZE, Implant, Endosseous, Root-Form, regulated at 21 CFR 872.3640 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jul 9, 2025. The decision came 167 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Paragon Implant Mfg., LLC has 3 other decisions in the tracker over the last 12 months: K250476 (NizPlant Dental Implant System), K251756 (Sterilization Trays), K251938 (GEN5 and GEN5+ Dental Implant System).

Questions & Answers

What did FDA clear under K252145?

K252145 is the FDA 510(k) for GEN5 and GEN5+ 3.3mmD Dental Implants, submitted by Paragon Implant Mfg., LLC. FDA's decision date was Dec 23, 2025, under product code DZE (Implant, Endosseous, Root-Form).

Who makes the GEN5 and GEN5+ 3.3mmD Dental Implants?

Paragon Implant Mfg., LLC, based in Calabasas, CA, is the applicant of record for K252145.

How long did the K252145 review take?

FDA received the submission on Jul 9, 2025 and issued its decision on Dec 23, 2025, 167 days later.

← All decisions in December 2025

Sources